NL1010386C2 - Anastomosis device. - Google Patents

Abstract

The invention relates to an anastomotic device for joining one end of a graft vessel to a target vessel at an opening made in the wall thereof The anastomotic device comprises a tubular body on which an outer flange, which comes into contact with the outside of the wall of the target vessel around the opening, and an inner flange, which comes into contact with the inside of the wall of the target vessel around the opening, are arranged. The inner flange is made up of a number of arms which are able to move from an extended position, located in the extension of the tubular body, under the influence of a pretension into a position extending in the lateral direction with respect to the tubular body, after the pretension has been released, in order to form the inner flange. The invention further relates to an anastomotic device comprising a tubular body with an outer flange and an inner flange thereon, the outer flange and optionally also the inner flange being cylindrically curved with a radius of curvature approximately equal to the radius of curvature of the target vessel.

Description

Anastomosis device

The present invention relates to an anastomotic device for connecting a graft vessel to a target vessel at a connection opening present therein.

Anastomoses can generally be divided into three types: so-called "end-to-side anastomoses" (abbreviated to ETS anastomosis), so-called "side-to-side anastomoses" (abbreviated to STS anastomosis), and so-called " end-to-end anastomoses "(abbreviated to ETE anastomosis). The anastomotic device according to the invention is applicable to any of these three types of anastomotic devices. An ETS anastomosis is understood to be an anastomosis in which an end of one vessel, the graft vessel, is connected to an opening formed in the wall of another vessel, the target vessel. This creates a kind of T-connection. An STS anastomosis is understood to mean an anastomosis in which the two vessels to be connected each have an opening formed in their wall, which openings are mutually connected. A so-called ETE anastomosis is understood to be an anastomosis in which two vessels are interconnected by connecting two vessel ends. This is, as it were, a continuous connection in which the vessels lie in line with each other, for example straight or obliquely at an angle to each other.

According to the invention, the connection opening can thus be both a lateral opening made in the wall of the target vessel in the case of an ETS or STS anastomosis and a terminal opening in the case of an ETE anastomosis. The terminal opening will then be defined by the section plane along which the target vessel is cut at its end.

According to the invention, the graft vessel and target vessel are in particular blood vessels, however, they can also be other hollow tubular organs such as ureters, fallopian tubes, etc. Within the scope of the present invention, the terms graft vessel and target vessel are used as distinctive terms which are to be distinguished between a first vessel (the graft vessel) and a second vessel (the target vessel). Thus, the terms graft vessel and target vessel are in no way intended to limit the invention. The terms target vessel and graft vessel can in many cases be interchanged throughout this application without departing from the scope of the invention.

Graft vessels that are used in practice and that can also be used according to the invention include: the vena saphena magna, which is usually loosened completely as a free graft (graft), but also known as in situ graft in peripheral vascular surgery. left in anatomical position and connected to neighboring leg arteries; the vena saphena parva, which is usually used for transplant purposes and is completely detached for this purpose; 10 - veins from the arms, which are mostly used for graft purposes; the thoracic artery interna, which is usually only loosened caudally and sometimes used as a free graft; the radial artery from the arm, which is used as a free graft; 15 - the gastro-epiploica dextra artery, which is usually only loosened caudally on the spleen side (transposate), and is sometimes used as a free graft; inferior arteria epigastrica, which is generally used as a free graft; vascular prostheses of plastic; veins or arteries of animal or human material, which are generally kept frozen.

An anastomotic device according to the invention can be used, for example, in the laying of a bypass in the case of, for example, a blocked coronary artery of the heart. Such bypass operations are performed on a large scale and hitherto attaching the graphite vessel to the target vessel has been entirely manual. Generally, an opening is then formed in the aortic wall where an end of the graft vessel is adhered to the edges of the opening by manual sewing. This connection is called the proximal anastomosis with the aorta. Correspondingly, the other end of the graft vessel is manually attached to the coronary artery 30 past the blockage. The latter connection is also referred to as distal coronary anastomosis. An experienced surgeon is able to accomplish a single anastomosis in about ten minutes by suturing.

Most bypass operations are further performed using a 1C '.:.

3 heart-lung machine, in which the heart is then temporarily stopped. Since this stopping of the heart can be harmful not only to the heart itself (after all, the heart will no longer receive blood), but also to other organs and bodily functions, it is important that the time that the heart is stopped is as short as possible. According to a recent development, more and more interventions are attempted on the beating heart, i.e. without a heart-lung machine and without stopping the heart. This because interventions on beating heart are less harmful to the heart and other organs and would be much cheaper. In such beating procedures on the beating heart, the blood flow at the site of a coronary artery to be diverted is temporarily interrupted. Even with such a bypass procedure on beating heart it is of great importance that the interruption of the blood flow lasts as short as possible, otherwise a heart attack can occur on the spot. An additional problem with bypass procedures on a beating heart is that in order to reach coronary arteries on the side and bottom of the heart, the heart must often be lifted, which is generally poorly tolerated by the heart and can lead to a drop in blood pressure or cardiac arrest. lead. An anastomosis that can be brought about quickly would make such an operation much more possible.

In addition to the recent development to perform more and more heart surgeries, such as bypass procedures, on the beating heart, there are also more and more surgeries that are performed via a small access route or thoracoscopically, whereby there is little or no possibility of using the hands. can bond. The object of the present invention is to provide an aid with which the connection of a graft vessel to a target vessel can be effected in a reliable and reproducible manner quickly, efficiently and with minimal burden on the patient. This object is achieved by providing attachments that can avoid or at least minimize the conventional, relatively labor-intensive, long-lasting, and, as a result, less predictable surgical procedures of the surgeon to the patient's body.

For the same purpose, WO-96/25886, from which an anastomosis device of the type mentioned at the beginning is known, proposes a large number of different accessories. The starting point is the philosophy that there should be no contact between the blood and foreign materials, which entails the aim of shielding all fittings to the interior of the vessels as much as possible by shielding 1 01 03 36 4 vessel wall material. However, the measures taken for this purpose - namely, coating all or as many internal, foreign parts as possible with the aid of the wall of the graphite vessel - result in a decrease / constriction of the available flow passage for blood.

Each of the fittings from WO-96/25886 also has many other drawbacks. In many cases the graft vessel has to be stretched, which is limited or not possible or only possible by constricting the graft vessel in another place. In addition, many fittings involve piercing the wall of the target vessel by so-called staples. These staples can be driven from the outside inward through the wall of the target vessel or from the inside out by folding legs outward through the wall of the graft vessel. Driving the staples through the wall, both from the inside and from the outside, requires tools to bend the staples. The necessary forces are exerted on the target vessel, among other things. When a staple or not with a calcified diseased vessel has to be driven inwardly from the outside through the wall, there is a risk that the staple does not push out the wall of the calcified diseased vessel, so that the staples are insufficient on the wall of can grip the barrel. In the case of WO-96/25886, the staples go from the inside out, they often penetrate both the wall of the aorta or coronary artery (the target vessel) and the wall of the graft vessel. If manipulation is required from the inside of the target vessel to drive the legs and the staples / staples attached to them through the wall of the target vessel from the inside, then an aid must be inserted either through the target vessel or through the graft vessel to be connected. the target vessel are introduced. In case the graft vessel with its other end is already connected to another target vessel, this means a further surgical intervention in the sense that the device has to be introduced somewhere through the wall of a blood vessel and that afterwards the a wall-mounted opening must be closed again. When parts of the fittings according to WO-96/25886 are introduced through the opening in the wall of the aorta or coronary artery, the target vessel, these parts 30 usually have circumferential dimensions larger than that of the opening, implying that the wall of the aorta or coronary artery at the site of the opening should allow stretch for insertion of the parts and the opening should subsequently narrow again. Particularly with diseased vessels this will generally not work or the wall will tear or the opening remains permanently too large. Furthermore, in WO-96/25886 all openings and also fittings are essentially round in shape, which will lead to problems when connecting a graft vessel to a coronary artery. In general, the diameter of the graft vessel is considerably larger than that of the coronary artery. the target vessel. This difference in diameter will result in connection problems with the circular or pure round ring shape and may impede the patency of the blood vessel. After all, the target vessel has a limited width that can only be stretched to a limited extent.

US-A-4,350,160 discloses an aid for connecting an end of a graft vessel to an end of a coronary artery. The methodology followed is cumbersome. A further drawback is that the coronary artery has to be cut transversely and this fragile coronary artery must then be bent around a part of the auxiliary instrument. The graft vessel is also bent over, after which both parts are stapled together.

Furthermore, WO-84/00102 discloses an apparatus for end-to-end (end-to-end) joining of vessels together. Here, too, the coronary artery must be run through transversely and then flipped over a number of pins, which in practice proves difficult, if not impossible, certainly with very small vessels, such as coronary arteries.

US-A-5,234,447 discloses an anastomotic device consisting of a ring 20 with staple legs pointing downwards from the bottom edge and further staple legs converted from the top edge upwards at their free ends. The graft vessel is passed through the ring with its end to be connected from top to bottom, this free end is turned outwards, after which the bottom staple leg is inserted through the folded part and then bent over and upwards, whereupon the whole of the graft vessel anastomosis device is inserted into an opening formed in the wall of the target vessel, and finally the lower staple legs and upper staple legs, in opposite direction through the tissue of the target vessel wall surrounding the openings of the target vessel and remain with their free tip end in this wall fabric of the target vessel 30. When the target vessel tissue is affected, such an anastomosis device is less useful due to the piercing of the wall tissue through the staple legs. A further problem may be that if the tissue of the target vessel wall is affected, this tissue would also readily

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6 can tear, making the connection unreliable. Also, insertion / insertion into the target vessel will be difficult here, since the staples of the bottom edge have a larger diameter than that of the opening in the target vessel.

US-A-4,366,819 discloses a four-part anastomosis device. This anastomotic device consists of a round, tubular body through which the end of a graft vessel to be connected is passed to be turned with its free end around the bottom edge of the tubular body. The folded-over part is secured to the tubular body by means of a ring with a triangular cross-section. For this purpose this ring is provided with radially inwardly pointing pointed members which engage in the folded-over part of the graft vessel. This prepared whole is inserted through an opening in the wall of a target vessel, after which the triangular section ring with its oblique top surface is inserted into abutment against the inside of the wall of the target vessel. On the outside of the target vessel, an outer flange is slid over the tubular body, which outer flange is provided with pointed elements pointing in the longitudinal direction of the target vessel, which are inserted from the outside into the wall of the target vessel. The outer and inner flanges are clamped together by a fourth loose part in the form of a ring which is fixable to the tubular body by means of an internal saw toothing, which co-acts with an external saw toothing applied to the tubular body 20. compression of fabric between the inner flange and outer flange is maintained. The drawback of this construction is that the inner flange, already prior to insertion into the target vessel, has its outwardly pointing shape, required for the flange action, and thus makes it difficult to insert the prepared whole into the target vessel. After all, the diameter of the whole to be inserted is greater than the diameter of the opening in the target vessel.

US-A-4,368,736 discloses an anastomotic device in which a connecting tube of non-tissue material is inserted on the one hand into the end of the graft vessel to be connected and on the other hand into an opening formed in the wall of the target vessel 30. The graft vessel and target vessel remain at a distance from each other. The connecting tube can herein have a bend so that on the one hand the connecting tube can be mounted at right angles to the target vessel and on the other hand the graft vessel, at least at some distance from the target vessel, can be inclined relative to the target vessel. J * W s * / '7 expired.

The object of the present invention is therefore in particular to provide an improved anastomotic device for connecting a graft vessel to a target vessel at an opening therein.

The aforementioned objects are achieved according to a first aspect of the invention by providing an anastomotic device for connecting a graft vessel to a target vessel at a connection opening therein, comprising: an essentially tubular body with a bottom edge to be directed towards the target vessel ; 10 - an outer flange mounted or mounted externally on the tubular body, which can be brought into contact around the connection opening against the outside of the wall of the target vessel; and an inner flange formed on the tubular body which protrudes in a free state with respect to the tubular body and can abut in overlapping relationship with the outer flange around the connection opening against the inside of the target vessel wall, and which during the insertion of the inner flange into the target vessel is in a substantially extended condition relative to the tubular body.

Preferably, the inner flange is reversible from that free state against a resilience bent into a biased state in which its projection on the plane stretched by the bottom edge of the tubular body lies substantially on and / or within that bottom edge such that it extends through the connection opening can be inserted into the target vessel, and is fixed in that prestressed state in such a way that the fixation is releasable to cause the inner flange to bend back in the direction of the free state under the influence of the pretension.

An important advantage of the anastomotic device according to the invention is, on the one hand, that the attachment to the target vessel takes place by clamping the tissue surrounding the connection opening between the inner flange and the outer flange. The quality of the wall of the target vessel will then hardly influence the strength of the connection of the anastomotic device with the target vessel. This is in contrast to staple-based compounds as known in the art. Another important advantage of the anastomotic device according to the invention is that the inner flange when inserting the anastomotic device through the connection opening in the target vessel. * Λ f--. · Λ. · "·> 8 is in a stretched, parallel or optionally oblique, inwardly pointing condition. This means that the inner flange is then not in a free-projecting position with respect to the tubular body, which means that the part of the anastomotic device to be inserted through the connection opening in the target vessel has a circumferential contour that is no larger is then the circumferential contour of the opening in the target vessel. The part of the anastomosis device to be inserted into the target vessel thus fits into that connection opening. Therefore, stretching the tissue of the target vessel around the connection opening or otherwise relatively complex manipulation in order to insert the anastomotic device into the connection opening is not necessary. The inner flange can be brought in whole or in part by mechanical or other means from the stretched state to the outwardly pointing free state in which it effectively forms the inner flange. It is preferred, however, when the inner flange is reversibly bent against a resilience from the free state to a pre-stressed position, i.e. during the insertion of the anastomosis device there is a pre-stressed stretched or inwardly pointing inner flange. This inwardly pointing may optionally be a right-angled inward direction, however generally the inwardly pointing will be rather a, preferably light (i.e. <15 °), tapered.

Such an anastomotic device with a prestressed, stretched inner flange has the advantage that the inner flange when initially applying the anastomotic device to the target vessel is essentially in line with the tubular body forward or inwards towards the centerline of the tubular body. (tapered in particular) and can therefore easily be inserted through the connection opening of the target vessel. After the inner flange has thus been inserted into the target vessel through the connection opening, its fixed prestressed condition can be released. The inner flange can then bend back to its free state in which it projects laterally or at least leans to protrude relative to the tubular body and with its side facing outwardly in the stretched / fixed state against the inside of the wall of the target vessel coming. The attachment to the target vessel is then accomplished by clamping the wall portion of the target vessel located around the opening between the outer flange and the inner flange. Releasing the fixed, prestressed state (or (j.

Stretched condition) of the inner flange, if the inner flange is made of a permanently resilient material, for instance to be realized by withdrawing a ring or sleeve arranged on the outside around the inner flange or a cord or other shape arranged around the inner flange. to remove obstacles. It is optionally possible to improve the abutment of the inner flange against the inner side of the wall of the target vessel with an aid, for example by placing a balloon in the target vessel at the location of the connection and inflating it or by using a other instrument to exert mechanical pressure so as to press the inner flange more tightly against the inner wall of the target vessel.

A still further important advantage of the anastomosis device according to the invention is that it minimizes or even completely avoids the protrusion of tissue from the graft vessel into the lumen of the target vessel, because virtually no internal parts within the target vessel need to be covered by the graft vessel and neither the graft vessel nor the bottom edge of the tubular body protrudes into the lumen of the target vessel, at least to an important extent.

A further important advantage of the anastomotic device according to the invention is that when the anastomotic device is fitted, the clamping force 20 exerted on the tissue around the connecting opening in the target vessel can be distributed evenly.

The anastomotic device according to the invention, as indicated at the outset, is applicable to all three types of anastomoses, i.e. ETS anastomoses, STS anastomoses and ETE anastomoses. In the case of an ETE anastomosis, the inner flange will preferably point inwards in the so-called stretched state. In the so-called free state and assembled state, they will be held in a forwardly stretched or slightly outwardly pointing state by the outer flange (which lies in the composite state around the target vessel). In case the outer flange is absent, and the inner flange is considered to be completely separate from the rest of the anastomotic device, it can assume a radially outward-looking shape in the free state. In the assembled state, this radially outwardly pointing state cannot occur due to the outer flange. In an ETE anastomosis, the outer flange will essentially take the form of a sleeve, possibly a cylindrical sleeve.

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In order to facilitate the placement of the anastomotic device under certain circumstances, it is advantageous according to the invention if the outer flange is a separate part with respect to the tubular body and / or inner flange, which is in the longitudinal direction of the tubular body and / or is slidable in the direction of the inner flange and can be locked by means of locking means relative to the tubular body and / or the inner flange. In this case, in the case of an embodiment of the invention intended for connection to a target vessel of the type in which the connection opening is formed in the wall (ie a so-called ETS or STS-10 anastomosis), the clamping force with which the wall portion surrounding the opening is formed According to the invention it is advantageous for the target vessel to be clamped between the inner flange and the outer flange to adjust the distance from the outer flange to the tubular body and / or the outwardly projecting inner flange. It is thus possible, for example, to realize a certain desired clamping force, depending on the thickness of the wall of the target vessel. The adjustability / adjustability can be continuous or discontinuous. According to an advantageous embodiment of the invention, the locking means comprise a saw-tooth mechanism. With such a sawtooth mechanism it is also possible to realize the adjustability / adjustability of the distance from the outer flange to the tubular body and / or the outwardly projecting inner flange. An ETE anastomosis can also be performed such that when the outer flange is displaced in the longitudinal direction of the tubular body, a compression force is applied to the vessel wall and thus the vessel wall is clamped between the outer flange and the inner flange.

In order to minimize or even completely avoid the use of auxiliary devices acting mechanically on the anastomotic device and / or the target vessel and / or the graft vessel, it is advantageous according to the invention if the inner flange is made of a super-elastic metal alloy or a thermally activated / activable shape memory alloy, such as a nickel-titanium 30 alloy. As an example of a nickel-titanium alloy, the material known under the brand name Nitinol can be used. Such a super-elastic metal alloy or a thermally activated / activable shape memory alloy has the property that it can be brought from a free state against a spring action to a deformed state and in that deformed state by means of a treatment , generally a cold treatment, can be fixed. When this fixation is then released, for example by heating the material above a certain temperature, the resilience counteracting the original bending will return and return the inner flange to its original free state.

According to a further advantageous embodiment of the invention, the inner flange has a bending axis extending tangentially with respect to the bottom edge of the tubular body, which lies at the inner circumference of the outer flange. In this way it can be achieved that the anastomosis device, when mounted on the target vessel, does not protrude into the target vessel, if at all. The inner flange then already bends into the opening through which it is inserted into the target vessel, and can then come into contact with the inner side of the wall of the target vessel flat from the inside and even be pressed slightly into the vessel wall consisting of flexible material. . Because the anastomosis device does not protrude or hardly protrudes into the target vessel, the blood flow through that target vessel will also not be obstructed or disturbed by parts projecting into the target vessel.

According to a further special embodiment, with which it can in particular also be realized that the bending center line of the inner flange lies at the inner circumference 20 of the outer flange or even above it, the inner flange comprises a number of mutually separated by cuts, recesses or folds. circumference of the tubular body distributed legs, the cuts or recesses or pleats preferably continuing up to or beyond the outer flange. In the case that the inner flange is built up of legs mutually separated by incisions or recesses, the inner flange can be regarded as a discontinuous flange, in the circumferential direction the mutually adjacent legs are always separated from each other by discontinuities or recesses. However, the flange can also be made in a continuous manner, for instance by designing it at least in a so-called stretched or inwardly pointing state, in which case the outwardly facing ridges of the pleats can be regarded as legs and the ones between these pleated backs. located fold valleys can be regarded as folds. The pleat valleys will then, when the inner flange moves from its prestressed state (the stretched or inwardly pointing 1 × 1 ioo 12 state) to its free state, be drawn flat (or at least be raised to a lesser pleat depth) to go into the free state of the inner flange while also being able to provide a continuous inner flange contact surface.

According to the invention, in order to increase the grip of the inner flange on the inner wall of the target vessel, it is advantageous if the surface of the inner flange facing the inner wall of the target vessel in the free state is provided with a roughening or unevenness. Optionally, that surface of the inner flange may also be provided with projections which can cooperate with recesses or holes formed in the surface of the outer flange facing the vessel wall. Such protrusions co-operating with recesses or holes can improve the anchoring.

Particularly when in an ETS anastomosis the graft vessel to be connected has a diameter greater than that of the target vessel - which is generally the case when connecting a bypass vessel to the coronary artery, the so-called distal anastomosis. According to a substantially separate aspect of the invention, according to a second aspect of the invention, it is advantageous if the bottom edge of the tubular body has a substantially oval or elliptical contour. When mounted on the target vessel, the longitudinal axis of the oval or ellipse will then extend substantially parallel to the longitudinal direction of the target vessel. According to the second aspect of the invention, however, a bottom edge of the tubular body with a substantially oval or elliptical contour is also advantageous in case the graft vessel has to be connected obliquely to the target vessel, such as with an ETS anastomosis regardless of the diameter ratio of graft vessel and target vessel may be the case, and may also be the case with an ETE or STS anastomosis. Such an oval or elliptical-shaped anastomotic device can also be realized very well by adapting anastomotic devices known from the prior art in that sense.

According to a third aspect of the invention, which can be used separately from the first and / or second aspect, but with great advantage also in combination with the first and / or second aspect, the invention relates to an anastomotic device 30 for connecting of a graft vessel on a target vessel at an opening therein, such as in particular an opening present in the wall thereof, comprising an outer flange which is intended to abut against the outer side of the wall of the target vessel with an outer flange contact surface around the opening brought,, ...

"·" Q? " ; The outer flange abutment surface is cylindrically curved, preferably with a radius of curvature equal to or approximately equal to the outer circumferential radius of the target vessel at the opening. By designing the outer flange abutment surface to be cylindrically curved, narrowing of the target vessel at and due to the anastomotic device is reduced or in case the radius of curvature is equal to or approximately equal to the external radius of the target vessel at the location of the target vessel. even completely prevent opening. Reducing the narrowing or completely excluding the narrowing of the target vessel at the location of the anastomotic device has the advantage that the flow through the target vessel at the location of the anastomotic device is less obstructed or even not obstructed at all. Such a cylindrical curved outer flange is particularly advantageous for an STS or ETS anastomosis. It will be clear that such a cylindrically shaped outer flange can also be realized very well by adapting anastomotic devices known from the prior art in that sense.

In order to further counteract compression of the target vessel and thus constriction of the target vessel at the location of the anastomotic device, it is particularly advantageous in this third aspect according to the invention if the outer flange contact surface is in the form of substantially a cylinder sector, which extends over a maximum of 180 °. Extending the cylinder sector beyond 180 ° is not entirely excluded, however this makes mounting the anastomosis device on and attaching it to the target vessel somewhat more complicated, since then either the target vessel must be squeezed to some extent to allow it to enter the cylinder sector portion of the outer flange, either the cylinder sector part must be flexible or flexible. The cylinder sector will preferably extend over a range of 150 ° to 180 °. By using such a cylinder sector portion for the outer flange abutment surface, it can be realized that the outer flange can support on tissue which lies around the target vessel, in particular tissue in which the target vessel is embedded. The tissue lying on / over the target vessel and possibly the tissue next to the target vessel is slightly removed or pushed aside, after which the outer flange can then sink into the tissue and still rest on it. It is clear that this narrows down the target vessel in a reliable manner.

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For applications in coronary artery surgery, according to an advantageous embodiment of the invention, in the distal anastomosis at the location of the coronary artery (which in general has a diameter of 1 to 2.5 mm), the radius of curvature of the outer flange abutment surface will lie in the range from 0.5 to 1.25 mm. In the case of a proximal anastomosis at the ascending aorta, which then generally has a diameter of 3 to 5 cm in situ, the radius of curvature of the outer flange contact surface will be in the range of 15 to 25 mm.

In order to realize a uniform clamping force around the opening in the target vessel in an anastomotic device with a curved outer flange contact surface, it is advantageous according to the invention if, when an inner flange with an inner flange contact surface is interrupted or not, the inner flange is cylindrically curved. designed with a radius of curvature equal to or approximately equal to the inner circumferential radius of the target vessel at the opening; or 15 is equal to or approximately equal to the radius of curvature of the outer flange contact surface.

The radius of curvature of the inner flange abutment surface in coronary artery surgery corresponding to the radius of curvature of the outer flange abutment surface will then preferably be in the range of 0.5 to 1.25 mm in the case of distal anastomosis with the coronary artery or in the range of 15 up to 25 mm in the case of the proximal anastomosis with the aorta.

In the proximal aortic anastomosis, the ascending aorta at the anastomosis has a (slight) curvature to the left side of the patient (from the surgeon's view to the right side). Thus, in order to further improve the connection, it may be advantageous if the outer flange contact surface and possibly also the inner flange next to the aforementioned cylindrical shape (in front / backward direction of the patient, the so-called sagittal plane) in the longitudinal direction of the aorta (or outer flange) is also concave in the case of the outer flange or convex in the case of the inner flange.

In order to fully establish the connection between the target vessel and the graft vessel, it is advantageous according to the invention if the anastomotic device further comprises coupling means for attaching the free end of the graft vessel (or target vessel) to the anastomotic device , for example the tubular body t0, - 15 thereof, or for attaching a first anastomotic device to a second anastomotic device, The attachment of the graft vessel (target vessel) could thereby take place directly on, for example, the outer flange or to a part which is integrally formed with the tubular body and / or the outer flange. Such a part formed as a whole with the tubular body can optionally lie inside the tubular body. However, attachment can also take place to a separate, loose part which, after attachment of the graft vessel, is coupled to the anastomosis device.

According to a further advantageous embodiment of the invention, the coupling means thereby comprise an accessory, which can be inserted at least partly into the tubular body, with a passage for the graft vessel, wherein the tubular body and / or the accessory are / are preferably provided with a stop which is such arranged to prevent the fitting from protruding beyond the bottom edge of the tubular body. In case the coupling means comprise a separate attachment insertable in the tubular body, securing the graft vessel outside the body to the anastomotic device is relatively simplified, the anastomotic device itself can be made relatively simpler, and the attachment of the anastomotic device on the target vessel can be realized relatively simply, since an aid can optionally be used here, which can be placed through the anastomotic device in the target vessel, after which it can be removed in order to finally connect the graft vessel to the target vessel. to be accomplished by means of the attachment.

The coupling means can thus comprise a separate part which is attached to the anastomotic device, for instance on the tubular body, for example after the tubular body has first been attached to the target vessel by means of the inner flange and the outer flange, but the coupling means can also be integrated in one piece with the anastomotic devices, for example with the tubular body, are formed, in which case generally the graft vessel will first be connected to the tubular body, and only then the tubular body will be attached to the target vessel through the inner flange and outer flange. In the latter case, the connection of the tubular body to the graft vessel can take place outside the patient's body, and in the former case, the connection of the graft vessel to the separate auxiliary coupling piece can take place outside the patient's body.

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In order to be able to connect the graft vessel without constricting it or possibly connecting it to the anastomosis device under minimal constriction, it is advantageous if the coupling means are arranged in a series distributed over the circumference of the tubular body or the separate fitting, by the tubular body or the separate auxiliary coupler going through suture passages, the passages preferably having a diameter of about 0.5 k 1.5 mm. With respect to the graft vessel or the tubular body or the auxiliary coupling piece, these passages will essentially run radially.

According to an advantageous embodiment of the invention, the coupling means comprise a flexible and / or resilient ring, which is dimensioned in such a way that the connecting end of the graft vessel can be passed through it and can be folded back over it, with an internal peripheral surface of the anastomotic device. preferably of the tubular body thereof, an inwardly opening circumferential groove is provided in which the ring can be received together with a part of the recessed end of the graft vessel, preferably in a form-fitting manner. Such a flexible and / or resilient ring in combination with a circumferential groove allows the anastomotic device to be first attached to the target vessel and then the graft vessel, after being provided with the flexible and / or resilient ring, to the anastomotic device. device is connected by deforming the flexible and / or resilient ring and inserting it into the anastomotic device and having it received in the circumferential groove, preferably in a form-fitting manner. It is advantageous to prevent the tomb vessel from loosening by allowing the circumferential groove to open obliquely downwards into the target vessel. According to an advantageous embodiment, manipulation of the flexible and / or resilient ring is facilitated when the ring has two or more rod-shaped parts which are essentially perpendicular to the ring, extend in axial direction thereof, and are attached at other ends on a flexible sleeve. By squeezing or otherwise deforming the flexible sleeve, the ring can then be deformed and manipulated via the rod-shaped parts in order to be able to insert it into the anastomotic device and place it in the circumferential groove.

According to a further advantageous embodiment of the invention, the coupling means may comprise an externally tapered sleeve, which is dimensioned such that the connecting end of the graft vessel can be passed through it and can be retracted therefrom, and a clamping ring which is intermediate from the narrow end the retracted portion of the burial vessel is slidable over the sleeve until clamped to the sleeve intermediate the retracted portion of the burial vessel. Such coupling means can be realized in a very simple manner and are also easy to use. The clamping ring and / or the externally tapered sleeve can herein be provided with locking means in order to be able to lock it with the rest of the anastomotic device to effect the connection of the grave vessel to the target vessel.

The coupling means as stated in particular in the claims 15-23 can optionally also be used completely independently of the aspects 1 to 4 according to the invention.

If a distinction is made in the coupling means between coupling means on the one hand where no separate, additional coupling accessories are required and, on the other hand, coupling means in which separate, extra coupling accessories are required, the following can be noted. Coupling means which do not require additional coupling accessories may, for example, comprise a ring of holes extending around the anastomosis device, which can be used advantageously in particular with ETS and ETE anastomoses. Such a ring of holes can be arranged in an upright ring-like or cylindrical part, which is placed on the outside of the external flange, and can be understood as the tubular body. Coupling means without additional accessories can also be considered coupling means for mutually coupling two anastomotic devices, for instance by providing one with an internal groove in which an external rib of the other fits, such as with STS anastomoses and also ETS and 25 ETE anastomoses can be helpful. As will be apparent from the figure description, various embodiments are conceivable here. In coupling means where one or more separate, additional coupling accessories are required, one can think in simple form for instance of a straight tube through which the grave vessel is inserted and with its end turned back around, after which a ligature or tie-rap is turned from the outside. after which the whole can then be placed and fixed in the tubular body, for instance by clamping or some form of coupling, such as a sawtooth mechanism or hook. But other possibilities are not only conceivable but also realistic, thought <c *. s. ·· 'r · / · *:; T> I v. · 5! For example, the use of a flexible ring around the end of the burial vessel, which ring is in turn insertable in a groove or slot formed in the anastomotic device, or on a sleeve through which a burial vessel is inserted and turned over at one end to be clamped onto sleeve 5 by means of a slide-on ring, which assembly can then be placed and fixed in the anastomotic device.

In order to further improve the connection of the graft vessel to the target vessel, in particular in the case of an ETS anastomosis when the target vessel is the coronary artery, according to a fourth aspect of the invention it is advantageous if the passage through the tubular body and / or the passage through the attachment insertable there and / or the coupling means are arranged such that the grave vessel is connected at an angle unevenly 90 °, preferably less than 70 °, such as, for example, 60 °, 45 ° or 30 °, relative to the target vessel. In case the passage through the tubular body is suitably arranged and / or the passage through the fitting insertable in the tubular body is arranged appropriately, this will amount to that the respective passage is placed obliquely with respect to the outer flange. The respective passage will then receive or be an extension of the end of the grave vessel to be connected during use. This fourth aspect can be applied separately from the first and / or second and / or third aspect of the invention, for example in the prior art, for example WO-96/25886, as well as in combination with the first and / or second and / or third aspect of the present invention. The advantage of an oblique connection of the grave vessel to the target vessel is that in the case of a bypass at the heart, the action of the pericardium or other structures, such as the lungs, on the grave vessel 25 in its vicinity decreases. Namely, with an (approximately) right-angled connection, such an action can easily lead to bending or kinking of the grave vessel or compression of the grave vessel or target vessel and thus obstructing the blood flow.

With an oblique connection of the burial vessel to the target vessel, the anastomotic device, at least one or more parts thereof transverse to the target vessel, will have a substantially oval or elliptical shape / contour. In the case of the connection of a grave vessel to a coronary artery, this oval or elliptical shape / contour will be much more pronounced than in the case of the connection of a grave vessel to the aorta.

ί 'J ö 19 »

In order to counteract rejection phenomena, it is advantageous according to the invention if the anastomosis device according to the invention is made of or coated with a material which is inert towards the human or animal body, such as high-quality stainless steels, titanium, and Teflon-like plastics or other plastics, whether or not on a Teflon basis.

In order to counteract clotting phenomena, it is advantageous according to the invention if the anastomotic device according to the invention, at least the inner flange and / or legs and / or the blood-contacting parts of the anastomotic device are covered with anticoagulant materials.

Such blood-clotting preventive or antagonistic materials are known per se, such as a carbon coating, a heparin coating or a so-called negative charge. A blood clotting inhibiting material is, for example, silicon carbon.

However, it is not excluded that the invention is applied in practice in combination with the use of rejection inhibitors and / or coagulation inhibitors (thrombosis inhibitors) by the patient.

The present invention will be explained in more detail below with reference to illustrative embodiments shown in the drawing. 1 shows schematically a graft vessel (bypass) between aortic ascendens and coronary artery of the heart, past a constriction / blockage in that coronary artery;

Figure 2 schematically and perspective, partly broken away, a three-part anastomotic device according to the invention for the ETS connection of, in particular, a graft vessel to a coronary artery, wherein the coupling (or attachment) between the (loose) coupling piece, with the graft vessel attached thereto, and the remainder of the anastomotic device disassembled at the opening in the coronary artery;

Figure 3 is a longitudinal sectional view of the three-piece ETS anastomosis device of Figure 2; Figure 4 is a cross-sectional view of the three-piece ETS anastomotic device of Figures 2 and 3;

Figure 5 is an exploded cross-sectional view of a three-piece ETS anastomotic device, very similar to the anastomotic device i U; c. from Figures 2, 3 and 4, however differs in that it concerns an anastomosis device, in particular the connection of a graft vessel to an aorta;

Figure 6 shows a detail of a longitudinal sectional view, essentially similar to that of figure 3, but now of a two-piece ETS anastomotic device 5 according to the invention;

Figures 7a to 7e show five detailed views corresponding to that of Figure 6, however showing in each case a different embodiment of a one-piece ETS anastomosis device according to the invention;

Figure 8 according to the invention shows a schematic perspective view 10 of an embodiment of a one-piece ETS anastomosis device with raised edge provided with radial passages;

Figures 9a and 9b show two variants of a two-part ETS anastomotic device according to the invention with an oblique connection;

Figure 10a shows a schematic cross-sectional view of a further embodiment 15 of a two-part ETS anastomotic device according to the invention, in particular showing an embodiment of the coupling means for connecting the graft vessel to the tubular body by means of a flexible and / or resilient ring;

Figure 10b shows a further embodiment variant of Figure 10a of the coupling means for connecting the graft vessel to the tubular body; Figure 11a is a schematic perspective view of a mounting aid for coupling the coupling means for attaching the free end of a graft vessel to the tubular body;

Figure 11b shows a detail in Figure 11a in section;

Figure 12 shows a still further embodiment of the coupling means for connecting the graft vessel to the tubular body by means of a tapered sleeve;

Figures 13 A to F show very schematically six anastomoses, two examples of each of the three types of anastomoses;

Figure 14 is a schematic sectional view, partly in elevation, of an STS anastomotic device according to the invention;

Figure 15 is a schematic sectional view, partly in elevation, of a second embodiment of an STS anastomotic device according to the invention;

Figure 16 schematically shows a detail of a cross-sectional view of a third ί n i π π λ | V, ^ v **, ^ 21 embodiment of an STS anastomosis device according to the invention;

Figure 17 is a schematic perspective view of an STS anastomotic device according to the invention;

Figure 18 shows a schematic sectional view, partly in view, of a first embodiment of an ETS anastomosis device according to the invention;

Figure 19 shows in schematic cross-section a detail of a second embodiment of an ETE anastomotic device according to the invention;

Figure 20 shows a detail of a longitudinal section of a third embodiment of an ETE anastomotic device according to the invention; Figure 21 shows a detail of a longitudinal sectional view of a fourth embodiment of an ETE anastomosis device according to the invention;

Figure 22 is a sectional view, in partial view, of a fifth embodiment of an ETE anastomotic device according to the invention.

With regard to the figures discussed above, it should be noted that they are all schematic in nature.

Figure 1, by way of application for an anastomotic device according to the invention, shows very schematically an aorta 1, a coronary artery 2 with a blockage 3 and a graft vessel 4, also called bypass. The graft vessel 4 is often a vein from the leg or (rare) the arm or an artery from behind the breastbone, a gastric artery, abdominal wall artery or an arm artery. However, other human vessels, animal vessels or artificial vessels can also be used in practice and can also be used with the aid of the invention, just like the aforementioned veins and arteries. Such a vein, artery or vessel generally has a diameter and vessel wall thickness greater than that of the coronary artery and less than the diameter and vessel wall thickness of the aorta. The diameter of the aorta in such cases generally ranges from about 3 to 5 cm. The diameter of the coronary artery, in which the blockage 3 is located, generally ranges from about 1 to 2.5 mm. Conventionally, hitherto, both in terms of proximal anastomosis 5 with aorta 1 and distal anastomosis 30 with coronary artery 2 to the aorta and coronary artery, have been attached by manual suturing. Since the diameter of the graft vessel 4 is larger than that of the coronary artery 2, in the distal anastomosis, the coronary artery 2 can be provided with a longitudinal incision with a length approximately equal to the width of the * C '«* HOO (U \ VJO · - o 22 pinched distal end of the graft vessel 4 or the graft vessel can be cut directly obliquely In that state, the graft vessel 4 is then sewn all around in a somewhat squeezed or ellipsoid state to the coronary artery.

It will be apparent from Figure 1 that the term target vessel is to be understood to mean both an aorta, a coronary artery or possibly another blood vessel or more generally a hollow tubular member, such as a ureter or fallopian tube.

Figures 2, 3, 4 and 5 schematically show embodiments of a three-piece ETS anastomotic device according to the invention. Figures 2, 3 and 4 show essentially the same embodiments in perspective view, partial exploded view, longitudinal section view and cross section view, respectively. The surrounding tissue shown in Figure 4 is not shown in Figures 2 and 3. Figures 2, 3 and 4 relate to a distal anastomosis, which is indicated by 6 according to the designation in figure 1, while figure 5 relates to a proximal anastomosis, which is indicated by 5 according to figure 1. The important difference between the anastomosis device of Figures 2-4 for the distal anastomosis 6 on the one hand and the anastomosis device of Figure 5 for the proximal anastomosis on the other hand, is that in the case of the proximal anastomosis the anastomosis device is essentially cylindrical of construction, whereas in the distal anastomosis the anastomosis device is essentially generally oval / elliptical in construction. With regard to the aorta, coronary artery and graft vessel, the same reference numerals are used in Figures 2-5 and also in the other Figures as in Figure 1.

The anastomotic device according to Figures 2, 3 and 4 consists of a tubular body 10 with legs 11 formed on a bottom edge 12, which are mutually separated by incisions 13, which are distributed along the circumference of the tubular body 10 in a finger-like pattern. are provided. The anastomosis device further comprises, as a separate part, an outer flange 14 disposed at one end of a cylindrical sleeve 15 and a coupling fitting 16.

The anastomosis device of figure 5 is constructed correspondingly and reference numbers have been used for the corresponding parts by 100, also with reference to corresponding parts to be discussed.

The sleeve 15, 115 is provided on its inside with two oppositely oriented ones

101 03G-O

23 »sawtooth profiling, a lower sawtooth profiling 17, 117 and an upper sawtooth profiling 18, 118. The lower sawtooth profiling 17, 117 can cooperate with the sawtooth profiling 19, 119 on the outside of the tubular body 10, 110 and the upper sawtooth profiling 18, 118 can cooperate with the sawtooth profiling 20, 120 on the coupling piece 16, 116. The respective sawtooth profiling makes it possible to successively first pass the tubular body 10, 110 with its legs through an opening 21, 121 formed in the wall of the target vessel 2, 1. then release the fixation of the prestressed state of the legs 11, 111 by heating, after which the legs 11, 10 111, due to the memory properties of the leg material, move from the state shown in figure 5 to the one shown in figures 2 , 3 and 4 shown can bend outwards (back) to abut against the inside of the wall of the target vessel 2, 1 around the opening 21 , 121, then passing the outer flange 14, 114 to abut the outside of the wall of the target vessel 2, 1 around the opening 15 21, 121 by passing the sleeve 15, 115 over the tubular body 10, 110 and sawtooth profiles 19, 119 and 20, 120 engage and slide relative to each other until a sufficient clamping force is established between the outer flange 14, 114 and the inner flange legs 11, 111, and then the coupling piece 16 , 116 with already mounted graft vessel 204 in the sleeve 15, 115, the sawtooth profiles 20, 120 and 18, 118 then engaging. The depth over which coupling piece 16, 116 can be inserted into sleeve 15, 115 is limited by the stop 27, 127 formed on coupling piece 16, 116, which engages in the deepest position on the top edge of the sleeve 15, 115.

It can thus be ensured that the bottom end 24, 124 of the coupling piece 16, 116 cannot come into the tubular body 10, 110 too deeply and thus protrude into the target vessel 2, 1. The limitation of the insertion depth can also be realized in other ways, for instance by forming an abutment on the inside thereof at the height of the lower edge 12 of the tubular body 110.

The connection of the graft vessel 4 with the coupling piece 16, 116 can be realized by inserting the graft vessel 4 through the passage 25, 125 into the coupling piece 16, 116 and then using radial suture passageways 26, 126 in the coupling piece 16, 116. graft vessel 4 to be attached to the coupling piece 16, 116 by suture. It is optionally possible, as in Figures 2-5, to i Li 5 U O O

24, tipping the graft vessel 4 around the bottom end 24, 124 of the connector 16, 116, which has the advantage that the contact of blood with the connector as well as contact of the blood with the end face edge surface of the graft vessel is avoided as much as possible . A further advantage is that when the adhesive connection 5 of the graft vessel 4 with the coupling piece 16, 116 turns over, this becomes stronger as a result of the greater number of points of engagement of the suture on the graft vessel. However, it is not absolutely necessary to fold the graft vessel 4 around the bottom end 24, 124 of the coupling piece 16, as will be seen or will appear from the above in Figures 7c-e.

The outer flange abutment surface located on the inner side of the outer flange 14 has a radius of curvature K which is substantially equal to the radius of curvature R of the target vessel 2, 1. The legs 11, 111, which in the free state shown in Figures 2-4 the so-called inner flange shapes (which can thus be a discontinuous inner flange) in their free state preferably have a shape / position corresponding to the radius of curvature K of the outer flange such that the legs 11, 111 extend substantially parallel to the outer flange 14, 114 so that the clamping force between the free-standing legs 11, 111 and outer flange 14, 114 is substantially equal everywhere.

Because the incisions 13 between the legs 11 extend up to the tubular body 10, it is possible to achieve that the legs 11 in free state with their top / outside as seen in figures 2-5 lie almost flat against the inside of the wall of the target vessel 2, 1. In the assembled state, the cuts then extend to or beyond (above) the outer flange.

Figure 4 further illustrates very schematically the advantage of an outer flange 14 in the form of essentially a half cylinder, or at least an outer flange, part of which has the shape of a half cylinder. The outer flange could in fact be rounded with only a part in the middle which is essentially in the shape of a half cylinder. The outer flange 14 with such a rounding is then somewhat saddle-shaped with a cylindrical center piece.

Figure 4 shows in cross-sectional view a coronary artery 2 which is embedded in adipose tissue 61 on the heart 60, at least prior to the application of the anastomotic device, the coronary artery 2, as shown by the shadow line 63, was almost entirely or entirely in the fat tissue 61 embedded.

1 U ï O O Ό o 25

Prior to applying the anastomosis device, the adipose tissue at 62 is scraped away to make coronary artery 22 accessible. The outer flange 14 can now rest with the longitudinal edges 64, provided with supporting ribs 65 (shown in Figure 4 and not shown in Figures 2 and 3), on the fat tissue 61, thus preventing coronary artery 2 from squeezing at the location of the anastomotic device. . This closing could easily be done since outside the fat tissue 61, in figure 4 on the upper side thereof, in practice there is still further tissue which can press the anastomosis device and / or the graft vessel 4 and thus the scraping away as a result. Press adipose tissue at 62 exposed coronary artery 2 at the location of the anastomosis device. Furthermore, the coronary artery can also be compressed by the weight of the anastomotic device itself.

In Figure 4 it is further illustrated that the legs 11 come into contact with their outer surface flush against the inner side of the wall of the target vessel 2, and that they then lie parallel to the outer flange 14 and thus, viewed in a plane transverse on the target vessel, curved along a circular arc V, which circular arc V is substantially equal to the radius of curvature K owing to the relatively small wall thickness of the target vessel 2.

As will be apparent from the foregoing, the anastomosis device of Figures 2-4 is essentially identical to the anastomosis device of Figure 5, except that the anastomosis device of Figures 2-4, such as in particular Figure 2 is clearly visible, as regards the parts which are essentially perpendicular to the target vessel 2, have an oval / elliptical shape. Such an oval / elliptical shape allows a graft vessel 4 with a relatively larger diameter to be connected laterally to a target vessel 2 with a relatively smaller diameter (relative to the graft vessel 4). This is particularly the case with the ETS connection of a graft vessel 4 to a coronary artery 2. The elliptical / oval shape in the embodiment according to Figures 2-4 thus returns in particular in the tubular body 10, the sleeve 15 , the coupling piece 16 as well as in the end of the graft vessel 4, 30 to be connected, which shape is not so much in advance as it has been brought into that shape. In the (proximal) anastomosis device of Figure 5, the tubular body 110, the sleeve 115 and the coupling piece 116 are substantially round in shape, i.e. viewed in a plane substantially transversely and horizontally in the plane of the drawing in Figure 5.

1 ü: u 'w b υ 26

It should be noted, however, that a proximal anastomotic device may also be oval or elliptical, similar to the distal anastomotic device of Figures 1-4. The graft vessel 4 will therefore have a substantially cylindrical shape 5 in the mounted state in figure 5. The proximal ETS anastomosis device of figure 5 is particularly suitable for connecting a vessel 4 of relatively smaller diameter to a vessel 1 of a relatively large diameter compared to the vessel 4.

As a variant of the embodiment according to figure 5, it should also be noted that it is also quite possible to choose instead of the cooperation of the sawtooth profiles 17,117 of the cylindrical sleeve 15/115 and the sawtooth profiles 20,120 of the coupling piece 16,116. for a cooperation of the sawtooth profiles 20,120 of the coupling piece 16,116 with sawtooth profiles of the tubular body 10,110 (not shown), which sawtooth profiles (not shown) would then have to be arranged on the inside of the tubular body 10,110. Obviously, the diameter on which the sawtooth profiles 20, 120 are arranged must also be adjusted further.

Figure 6 shows, relative to the longitudinal direction of the target vessel 2, or if desired 1, a longitudinal section, at least detail thereof, of a two-part ETS anastomotic device according to the invention in mounted condition. The essential difference with the three-part embodiment from Figures 2-5 is that the tubular body 10 and the sleeve 15 from the three-part embodiment are integrated into one unit, the tubular body 30 in the two-part embodiment shown in Figure 4. parts are substantially identical, at least may be those in the three-part embodiment of Figures 2-5, the two-part embodiment of Figure 2 uses the same reference numbers and characters for corresponding parts. For all these reference numbers, it is possible to read a reference number increased by one hundred (cf. figure 5).

Since the sleeve 15 and the tubular body 10 of the three-piece embodiment are integrated into one unit in the two-piece embodiment, the sawtooth profiles 17 and 18 in the two-piece embodiment can thus be dispensed with.

Furthermore, in figure 6 it is indicated by means of the shadow line 31 that the outer flange 14 has a saddle shape with a view in the transverse plane, i.e. a plane

1 U i u o ^ O

27 »perpendicular to the plane of the drawing, a radius of curvature K. Also the legs 11 in their free state again lie essentially parallel to the outer flange 14, and, considered again in a transverse plane transverse to the plane of the drawing, with a radius of curvature in substantially equal to K. Such a saddle-shaped outer flange 5 is also applicable in the so-called one- and multi-part embodiments of the anastomotic device.

As a variant of the embodiments according to figure 6, it should also be noted that a two-part embodiment can very well be realized in which the outer flange forms part of a separate part, the first part, and that the coupling piece 16 and the tubular body 10 one whole, the second part, are integrated. In contrast to the two-part embodiment according to figure 6, no stop 27 is then required which forms a limit to the extent to which the bottom edge 24 of the coupling piece 16 can insert into the target vessel.

After all, the coupling piece 16 and the tubular body 10 are then integrated into a one-piece unit, wherein the positioning of the bottom edge 24 of the coupling piece relative to the rest of this part is also already determined in advance during the design.

Such a variant of the two-part embodiment, in which the outer flange 14 forms a separate part that is separate from the rest, can for instance be realized very easily by providing the tubular body 10 on the outside with the tubular body 10 according to the embodiment according to Figures 2 and 3. a sawtooth profiling and reducing the coupling piece 16 in diameter so that it fits inside the tubular body 10 and can be molded or connected therewith.

Fig. 7a shows, viewed on the longitudinal direction of the target vessel 2, or if desired 1, in longitudinal section, at least a detail thereof, a one-piece ETS anastomosis device according to the invention in mounted condition. The difference with the two-part embodiment of figure 6 is that the fitting 16 is now integrated with the tubular body 30 into one whole, namely the tubular body 40. Regarding the three-part embodiment of figures 2-5, the difference is that the tubular body 10, the sleeve 15 and the fitting 16 are integrated into one unit, namely the tubular body 40. Due to the integration of the fitting 16 with the tubular body, as will be appreciated, at least ...

28 With respect to the two-part embodiment according to Figure 6, the upper sawtooth profiling 18 and the sawtooth profiling 20 in the one-part embodiment are omitted, compared to the three-part embodiment all sawtooth profiling can be omitted.

Since the parts of the one-piece embodiment according to Figure 7a are otherwise substantially identical, or at least may be identical to those in the two-part and three-part embodiment, the same reference numbers / characters have been used for this and these parts need no further explanation.

The one-piece anastomotic device 40 according to Figure 7a essentially consists of an outer tubular part 41 and an inner tubular part 42 with a downwardly opening slot between which the folded end part 43 of the graft vessel 4 can be received. This folded-over part 43 of the graft vessel 4 can then be secured by suturing via radial suture holes 26 formed in outer tubular part 41.

Figure 7b shows a one-piece ETS anastomotic device 50 in a similar manner to that shown in Figure 7a. This one-piece anastomosis device 50 differs substantially from the one-piece anastomosis device 40 of Figure 7a in that the suture holes 26 are formed by the connecting portion 44 interconnecting the outer tubular portion 41 and the inner tubular portion 42. The lower portion of the inner tubular portion 42 may be bent slightly inwardly with respect to the tubular body 50 as a whole to facilitate insertion of the folded-over portion 43 of the graft vessel 4 therebetween, after which this portion 42 is positioned in the arrow direction of the outer tubular portion 41 to bend to clamp the folded portion 43 between portions 41 and 42. This bending back of the part 42 will preferably be done mechanically. The manner of clamping of the folded-over edge part 43 by bending back part 42 according to arrow 7b can also be used in the embodiment according to figure 7a.

Figure 7c shows a still further embodiment of a one-piece ETS anastomosis device 60. This one-piece ETS anastomosis device 60 as such again resembles the one-piece ETS anastomosis devices 40 and 50 of Figures 7a and 7b. The big difference is that here the end of the graft vessel 4 is not folded over, but is directly attached to a tubular part 45 by means of suture passages 26 and clamped to the lower end by means of lips 46 which are bendable according to the arrow. Support ribs 47 (cf. Figure 7d and Figure 7e) may be formed between the roots 48 of circumferentially adjacent lips on which the head end 49 of graft vessel 4 abuts to prevent it from coming into contact with blood.

As can be illustrated with reference to Figures 7a-7c, the attachment of the graft vessel to the anastomotic device can also be done by clamping the end of the graft vessel. In Figures 7a and 7b, the end 43 of the graft vessel 10 is then clamped, optionally using the first aspect of the invention, between the parts 41 and 42 of the anastomotic device and in Figure 7c the clamping of the end of the graft vessel then takes place between the parts 45 and 46. The fixing by means of suture, as shown in figures 7a-7c, can then possibly be omitted completely, which implies that the suture holes 26 can thus be completely absent. In order to improve such clamping of the end of the graft vessel, it may be advantageous to have parts 41 and / or 42 in the case of Figures 7a and 7b or parts 45 and 46 in the case of Figure 7c at their clamped end portion provide the side of the graft vessel with a roughening, profiling, protrusion, etc., in order to anchor the end of the graft vessel as it were. It is optionally possible to provide a projection on one of the clamping parts, the end of which, in the clamped state, is received in a recess in the opposite clamping part.

Figure 7d shows a further variant of a one-piece anastomosis device 70, which bears much resemblance to the one-piece anastomosis device 60 of Figure 7c. The difference is that here viewed in the cylindrical portion 45 in the circumferential direction, two rings with suture passages 26 are provided instead of one, as in figure 7c and otherwise also in figure 7b, 7a and the figure 7e to be discussed. Furthermore, the clamping lip 46 is omitted and, at the location of the root 48, a continuous circumferential support rib 47 is provided on the inside, on which the head end 49 of the graft vessel 4 can abut and close with respect to the blood.

Figure 7e shows a particularly advantageous embodiment, which is a direct variant of the embodiment of figure 7d. The anastomotic device 80 shown in Figure 7e differs from that in Figure 7d in that the cylindrical portion 45 is of very short design and has only one ring with suture passages 26 arranged circumferentially. A great advantage of the anastomotic device 80 is that the graft vessel 4 can be connected obliquely here relatively easily, as is also indicated in figure 7e.

With regard to the embodiments of the anastomotic devices 70 and 80 of Figures 7d and 7e, it should be noted that the clamping lips 46 of Figure 7c could also be used here.

The anastomotic device 80 shown in detail in a longitudinal section in figure 7e is also shown in perspective in unassembled state, with legs 11 still stretched. This figure will speak for itself.

With regard to the embodiments of the anastomosis device as shown in Figures 6 and 7a-7e and Figure 8, it should be noted that the outer flange 14 can be designed as shown in solid lines in Figure 8, ie as a half cylinder, or a cylinder sector extending over approximately 180 °. However, the outer flange 14 can also take a very different form, such as, for example, a saddle shape, which is schematically shown in broken line 31 in Figure 8.

It is further noted that the anastomotic devices as shown and described with reference to Figures 6, 7a-7e and Figure 8 can also be used very well in accordance with the embodiment sketched in Figure 5, in which case essentially all transverse to the target vessel upright parts with a round outline.

The remarks made in the previous two paragraphs with regard to Figures 6, 7a-7e and 8 also apply equally well to Figures 10, 11a, 11b and 12 to be discussed below, as well as Figures 9a and 9b and further discuss figures.

Figures 9a and 9b schematically show two further embodiments of the ETS anastomotic device according to the invention. These embodiments are designed such that graft vessel 4 can be connected to the target vessel 2 at an angle of approximately 45 °. This has been achieved in the embodiment of Figure 9a by placing the tubular body 30 of the two-piece embodiment of Figure 6 obliquely on the outer flange 14 and the tubular body 16 of the coupling piece "if" OQ O C; f 1 o '«, -' vy 31 to be placed diagonally and cut diagonally. In the embodiment according to figure 9b this has been achieved by providing the tubular body 16 with an oblique passage, at least starting from the two-part embodiment according to figure 6. This further implies that the outer flange 14 also comes partly inside the sleeve 30. lie. Otherwise, the embodiments of Figures 9a and 9b are essentially identical to the embodiment of Figure 6.

It will further be clear that the oblique connections shown in Figures 9a and 9b are also feasible in the one-part and multi-part embodiments described previously and to be described above, so that it will be clear that the oblique connection is certainly not part of the two-part design. embodiment is limited.

Referring to Figures 10a and 10b, a further mounting option for attaching the graft vessel 4 to the anastomotic device according to the invention is shown on the basis of a further embodiment of a two-part anastomotic device according to the invention which has not been described before. Before going into this method of fastening, however, it is pointed out, which will also be obvious that this fastening method is also very applicable in the two and multi-part embodiments of anastomotic devices according to the invention. The graft vessel 4 is folded at its lower end around a flexible and / or resilient ring 92 located in the folded-over portion 91. The folded-over portion 91 is attached to graft vessel 4 in the circumferential direction above the ring 92. The anastomotic device is further provided with a groove which opens essentially in the direction of extension of the wall of the target vessel 2, ie an inwardly opening groove 93 relative to the tubular body 94 of the one-piece anastomotic device. to manipulate previously prepared graft vessel 4, which has thus been turned over and provided with a flexible and / or resilient ring 92, thereby squeezing the ring 92 together and releasing it again, placing the ring 92 in the circumferential groove 93 and to anchor. With a suitable choice of material of the resilient ring 92, a firm and reliable connection between the graft vessel 4 and the anastomotic device will also be obtained in this way.

Figure 10b shows a variant of the embodiment according to Figure 10a, at least a detail of such a variant. The difference is that the groove 96 (which functionally corresponds to groove 93) is designed to open slightly downward. On the one hand, this makes it easier to receive the folded end of the graft vessel 4 with resilient ring 92 on the one hand and, on the other hand, it increases the resistance to pulling the graft vessel 4 and the target vessel 2 apart in the direction of arrow 97. For the sake of clarity, it should be noted that in figure 10b the top side is the outside of the target vessel 2 and the bottom side is the inside of the target vessel 2.

Figure 11a shows a graft vessel 4 surrounded by a sleeve 200, which sleeve 200 is provided with at least two rod-shaped parts 201 connecting the sleeve 200 to the resilient ring 92. Now squeezing the sleeve 200 in one or the other direction the ring 92 will also be deformed via the rod-shaped parts 201. It will be clear that this considerably facilitates manipulation of the graft vessel for securing this graft vessel 4 to the anastomotic device. Once graft vessel 4 has been secured to the anastomosis device, the rod-shaped parts 201 can then preferably be cut as close as possible to the ring 92, after which the cut parts thereof can be removed together with the sleeve 200 from the graft vessel 4. For this purpose, the sleeve 200 will be cut in its longitudinal direction or may have already been cut in advance so that it can be folded open and removed from the graft vessel 4.

In order to promote proper insertion and pressing of the ring 92 into the circumferential groove 93, 96, it is advantageous if the rod-shaped parts near the ring 92 assume the direction in which the circumferential groove 93, 96 opens or at least on the side of the circumferential groove opening facing away from the circumferential groove opening. ring are attached to it. This is illustrated in Figure 1 lb.

The elastic and / or resilient ring 92, as explained with reference to Figures 10a, 10b and 11a, is shown in particular in Figure 11a as a more or less round ring. Such a round ring can optionally also be used when the anastomotic device, at least the parts thereof transverse to the target vessel, have a substantially oval or elliptical shape / contour. However, with such a substantially oval or elliptical shape / contour of the anastomotic device, the ring 92 can advantageously also have a corresponding oval or elliptical shape. It is further noted that if the graft vessel is cut obliquely, or at least folded diagonally around the ring 92, this type of coupling is also applicable for oblique connections.

i o i n o p un

I O ί o --j O U

33

Figure 12 shows a still further variant of a possible way in which the graft vessel 4 can be attached to the anastomosis device. The graphite vessel 4 has been inserted with its end to be connected through a sleeve 205 and with its end turned back around that sleeve 205. The sleeve 205 will preferably widen in the direction away from the connecting end, which among other things facilitates an oblique connection of the graft vessel 4, since this then has some freedom of movement in the sleeve 205. In order to fix the graft vessel 4 on the sleeve 205, a clamping ring 206 is pushed over the folded end edge part 207 of the graft vessel 4 and clamped, the folded wall part 207 of the graft vessel 4 being located between ring 206 and the sleeve 205. For mounting in the rest of the anastomotic device, the ring 206 and / or sleeve 205 may then be provided on their outside with, for example, a sawtooth toothing (not shown) or other form of attachment and anchoring (for instance a resilient clamping connection) to the anastomotic device. For example, the sawtooth toothing 6 of figure 2-4 can be envisaged and furthermore also has a stop edge 27 (also not shown), compare figures 2-4 again.

Figure 13 shows very schematically six anastomoses, of each of the three types two. The various aspects of the present invention are applicable to any of these types of anastomoses.

Figure 13A shows an ETS anastomosis, with the graft vessel mounted at right angles to the target vessel with one end. Figure 13B also shows an ETS anastomosis, however the graft vessel is attached to it obliquely to the target vessel. If the grave vessel has a diameter larger than that of the target vessel, the connection opening will be elliptical or oval-shaped, both in the embodiment according to figure 13A and in the embodiment according to figure 13B. When the diameter of the graft vessel is smaller than that of the target vessel, the connection opening can be round or elliptical / oval-shaped. This applies to both the anastomosis according to figure 13A and the anastomosis according to figure 13B. In the case of the anastomosis according to Figure 13B, however, a round connection opening does imply that the graft vessel in the vicinity of the connection opening has an unround cross-section, although this out-of-roundness can hardly be seen visually.

Figures 13C and 13D each show a so-called STS anastomosis. Figure 13C refers to an STS anastomosis in which the interconnected vessels 1010306 34 run in parallel and the anastomosis shown in Figure 13D refers to two interconnected, intersecting vessels. The connection opening can have a round or elliptical shape here. When graft vessel and target vessel run parallel, the opening will usually be oval / elliptical. In vessels crossing at an angle, the diameter of the opening can often not be larger than the width / diameter of the smallest vessel, which often leads to round openings.

Figures 13E and 13F each show an ETE anastomosis. Figure 13E refers to mutually connected, transversely cut drums, whereby in the case of round drums the connection opening will also be round. In the case of Figure 10 13F, the vessel ends to be connected to each other are cut at an angle. When the skew of the cuts is the same and the vessels are positioned in a suitable position relative to each other, a straight-through connection is shown in Figure 13F (shown in solid lines). However, it is also possible to interconnect the vessels at an angle to each other. To illustrate this, a right-hand barrel is also shown in broken lines. Both vessels can then be cut obliquely at their connecting end, but one vessel can also be cut straight, in accordance with Figure 13E. In the embodiment of Figure 13F, the connection opening will generally be oval or elliptical in shape.

Figures 14-17 show schematic examples of an STS anastomotic device according to the invention.

The anastomotic device of Figure 14 is roughly comparable to the embodiment of Figure 5 and consists essentially of two anastomotic device halves. The lower half is essentially identical to, or at least conceivable in this way, the lower tubular body 110 with legs 111 and sleeve 115 with outer lens part 114. The difference is that the coupling piece 116 has been replaced by the upper half of the STS shown in figure 14. -anastomosis device. This upper half also consists of a tubular body 110, the upper tubular body (which may be substantially identical to the tubular body 110 of the lower half), on which the upper outer flange 214 is mounted by means of an external toothing. The upper outer flange 214 is integrally formed with the bush 115 and via that bush 115 also integrally formed with the lower outer flange 114. The upper tubular body 110 can be inserted into the sleeve 115 with its lower end (as seen in the representation in Figure 1), and then be locked therein by means of the teeth. With a suitable design of the teeth and round shapes, it is possible to make the lower half and upper half rotatable relative to each other.

It will be clear that, if desired, in the embodiment of the STS anastomosis according to figure 14, the tubular body 110 of the top half and bottom half and the sleeve 115 and the outer flanges can also be designed as a whole (i.e. a part). Furthermore, it is also conceivable, in deviation from what is shown in figure 14, to design the outer flange 214 (or optionally 114) as a component with respect to bush 115 and the other outer flange 114 (respectively 214). A still further variant of what is shown in Figure 14 is that the upper tubular body 110 may have an external toothing which meshes with an internal toothing in the lower tubular body 110.

Figure 15 shows a further variant of an STS anastomotic device according to the invention. This STS anastomosis device consists essentially of two parts.

On the one hand the tubular body 12 with the upper and lower inner flange 11 integrally formed therewith, and on the other hand a sleeve and outer flanges 300, which are formed as an outer part. It will be clear that the outer part and the tubular body 12 can also be integrated as a whole. The STS anastomosis device will then become one-piece. Furthermore, it will be clear that the outer flanges 300, as shown by dashed line 301, can also be designed as two parts, for example two cylindrical parts (compare 314 of figure 17). Furthermore, it is also readily apparent that the outer part 300 can optionally also be omitted completely, wherein the vessels 2 and 4 then lie directly on top of each other around the anastomosis and are pressed.

Figure 16 shows a further variant of an STS anastomosis device according to the invention. The STS anastomotic device of Figure 16 consists of two tubular bodies having an inner flange and an outer flange formed integrally therewith, the respective outer flanges 205 being interconnectable for rotation pivot 206, 207 permitting rotation about axis of rotation 200. Such a rotary connection can in simple form comprise an annular rib 206 and an annular recess 207, which can then interlock with each other. With a suitable embodiment of the rib 206 and recess 207, a mutual coupling can also be realized here, which prevents disassembly in the axial direction of the axis of rotation 200. This can be realized, for example, by designing the recess 207 as a back-cut slot and by shaping the rib 206 accordingly, so that it can be received form-fitting in the slot 207. The upper and lower halves of the STS anastomotic device can be ensured in the embodiment according to figure 16, if necessary, in addition to or replacing the coupling action of the rib 206 and recess 207, by using essentially U -shaped clamping pieces 208 which hold the outer flanges together after being slid on them in accordance with arrow 209, and which allow rotation of the lower half and upper half about axis of rotation 200 relative to each other. The U-shaped clamping pieces can be designed as one or more separate parts. It is optionally possible to design clamping piece 208 as a ring, interrupted or not.

Figure 17 shows in perspective view a still further variant of an STS anastomotic device according to the invention. As in the embodiment of Figure 8, the outer flanges 314 are cylindrically curved with an internal radius of curvature approximately equal to the external radius of curvature of one vessel 2 and other vessel 4. The radii of curvature of the outer flanges may be dependent on that of the vessels 2, 4 differ. The legs forming the inner flange are indicated by 311. Coupling flanges 312 are mounted on the respective STS anastomotic devices directly to the outer flanges and / or tubular members or via connectors 313. By placing these coupling flanges 312 together and fixing them together, the interconnection between vessels 2 and 4. For the mutual fixing of the coupling flanges 312 use can be made of clamps, as indicated with 208 in figure 16, and / or of a slot / rib assembly as shown in figure 16 with 207/206, and / or of other fastening means . When the coupling flanges 312 are round, a mutual rotation of the vessels 2, 4 around an imaginary connecting axis is possible.

Figures 18-22 show exemplary embodiments of ETE anastomoses.

The ETE anastomotic device shown in Figure 18 essentially corresponds to the ETS anastomotic device shown in Figure 4. The essential difference is that the target vessel 2 here is an extension of the graft vessel 4 and that the outer flange 15 has essentially a tubular shape and that the inner flange legs 11 extend essentially in the longitudinal direction of the target vessel. status.

When unassembled, the inner flange legs, as shown by dashed lines, will point inward to facilitate insertion of the inner flange into the target vessel. In a similar manner as in the embodiment according to Figure 4, the pretension present in the inner flange legs 11 can be released, after which they can occupy the position shown by solid lines.

Figure 19 shows a further variant of an ETE anastomosis device according to the invention. This ETE anastomosis device is essentially very similar to the ETS anastomosis device of figure 6. The difference here again is as with figure 18, that the outer flange is an essentially tubular body and that the inner flange legs are mounted extend substantially parallel to the target vessel. By extending the leg 210 of the coupling piece 27 it is possible to achieve that the parts of the anastomosis device which come into contact with the bloodstream are almost completely covered with blood vessel tissue.

Figure 20 shows a variant of the ETE anastomosis device of Figure 19. The difference here is that the tubular body 30 is outwardly deflected, and that extension of leg 210 is no longer present. This ETE anastomosis device is particularly suitable for connecting vessels of approximately equal diameter end-to-end.

Figure 21 shows a still further variant of an ETE anastomosis device, which is constructed in one piece. This ETE anastomosis device essentially shows great similarity to the ETS anastomosis device of figure 7a. As with Figures 17 and 18, the essential difference from the comparable ETS anastomotic device is that the outer flange is constructed as a tubular body and that the inner flange legs, at least in assembled condition, run parallel to the target vessel. The embodiment shown in figure 21 is also particularly suitable for connecting vessels of approximately the same diameter to one another. Considering Fig. 21 and Figs. 7a to 7d, it will be clear that according to the variants shown in Figs. 7b to 7d, three variants are clearly conceivable. However, as with Figures 7a to 7d, it will be clear that many variants within the scope of the invention are also conceivable with Figure 21.

Figure 22 shows a still further variant of an ETE anastomosis device, which is constructed in three parts. This ETE anastomotic device essentially resembles the ETS anastomotic device of figure 5. With the proviso that the coupling piece 116 of figure 5 is omitted and has been replaced by a second tubular body 110 with an integrated inner flange in the form of legs 111 and a second outer flange 114 integrated with the sleeve 115. The outer flanges 114 are essentially cylindrical in order to enclose the end of a graft vessel or target vessel. The inner flange, in particular the legs 111, are also essentially cylindrical, with the proviso that they are loaded with a radial releasable bias.

As will be apparent with reference to Figures 14-22, this essentially eliminates the distinction between a graft vessel and a target vessel. The distinction here is more linguistic in order to be able to distinguish between one vessel and another vessel.

As may be particularly apparent from Figures 14 and 16, it may be particularly useful in STS anastomotic devices when an anastomotic device is used here which has a rotational freedom about a longitudinal axis extending through the connection openings. This is because the vessels to be mutually connected then still have some freedom of movement relative to each other at the location of the connection and can thus adapt to changing conditions in the body, and to allow the vessels to have different angles relative to each other during the making of the connections. making the diversion of the diversions less likely to occur. It will be clear, however, that it is also essentially possible to provide an ETE anastomotic device or an ETS anastomotic device with a freedom of rotation, such that one vessel, the graft vessel, with respect to the other vessel, is the target vessel. is rotatable about a longitudinal axis passing through the connection opening of both vessels or one of the vessels. In the case of an ETS anastomosis device according to Fig. 13B, this could be a centerline drawn there, however the graft vessel branching at an angle must then have a round shape at the location of the connection in a cross-sectional plane perpendicular to that centerline. The invention therefore relates, according to a fifth aspect, which can be seen completely separately from the aspects 1 to 4 or in any combination with one or I 0 iu 3 bb (39 more of those aspects 1 to 4). anastomotic device comprising a first anastomotic device for attachment to one vessel and a second anastomotic device for attachment to the other vessel, which anastomotic devices have an essentially round shape and are rotatably interconnectable.

As may be clear from the foregoing, the number of parts, including the coupling means with which a graft vessel or target vessel can be fixed, can consist of one or more parts. Particularly distinguishable are the one-piece shape, the two-piece shape, the three-piece shape, the four-piece shape, the five-piece shape, and more than five piece shapes.

In the one-piece form (see, for example, Fig. 7a-e, 8, 21), graft vessel and target vessel are both attached to one part, using at least one of the vessels the first aspect of the invention. The other vessel can optionally be attached to the same part in a different manner. This will generally be the case with ETS and ETE anastomoses, where the target vessel is clamped according to the first aspect of the invention and the graft vessel is otherwise attached to the same part. However, both (target vessel and graft vessel) can be attached to the same part in an ETS, ETE and STS anastomosis according to the first aspect of the invention.

The two-piece form (see, for example, fig. 6, 9a-b, 10a-b, 15, 16 (without optional part 208), 17, 19 and 20) consists of two separate parts that are connected to each other. It may be the case that first the graft vessel and the target vessel are each separately attached to a separate part, but it is also possible that for fixing the target vessel use is made of a separate inner and outer flange, the graft vessel directly on the tubular body or the outer flange is attached. The coupling can then take place with the aid of, for example, snap hook and / or sawtooth profiles or other locking means, such as, for example, a bayonet closure, which are integrated per se in these two parts and are not loose. Use is made here of two parts, wherein the first aspect of the invention is applied in at least one vascular coupling. These types of connections are well conceivable for ETS and ETE anastomoses, where an extra loose coupling is used. However, the vessel coupling can also work according to the first aspect of the invention with both vessels, in which one part can optionally be attached to the target vessel and the other part to the graft vessel. In general, this will be the case with STS anastomoses, but this is also very possible with ETS and ETE anastomoses and can offer major advantages.

The three-piece mold (see, for example, Figs. 2, 3, 4, 5, 14, 16 (with item 208), 18, 22) consists of three separate parts, at least one vessel coupling operating according to the first aspect of the invention. It may be that the graft vessel and the target vessel are each separately attached to a separate part, after which a separate third part 10 is then used for the interconnection of the vessels. It is also possible that this third part is a common double outer flange (see for example figures 14 and 22) or double inner flange. This three-part form can occur with STS anastomoses, but also with ETS and ETE anastomoses. Furthermore, in the three-part shape, it is also conceivable that for fixing the target vessel use is made of a separate inner and outer flange, the graft vessel being attached to a separate loose coupling piece. The coupling of the parts can then take place by means of, for example, snap hook and / or sawtooth profiles or other locking means, such as, for example, a bayonet fitting, which can be integrated per se in the tubular body or the outer flange (and therefore not separate therefrom to be). This shape appears to be very suitable for 20 ETS and ETE anastomoses, although this shape is also conceivable for STS anastomoses.

The four-piece form (see, for example, Fig. 12 in combination with Fig. 2-5) uses four parts which are connected together, at least one vascular coupling according to the first aspect of the invention being provided. Usually this form will consist of two separate parts for the target vessel and the graft vessel, respectively, whereby it is quite possible for both vessels to use the principles according to the first aspect of the invention. After the two parts have been attached per target and graft vessel, both pairs are coupled to each other by means of integrated coupling means, such as, for example, snap, hook and / or sawtooth profiles or other locking means, such as, for example, a bayonet closure. The four-piece shape can occur with any of the three types of anastomosis device, but appears to be particularly attractive with STS anastomoses.

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41

The five-part form uses five parts that are connected together, at least the first aspect of the invention being applied. This system works as the four-piece shape, however an additional loose part is used to interconnect the 5 parts attached to the target vessel and graft vessel. This form is well applicable for all types of anastomoses and very attractive especially for STS anastomoses.

The more than five-part shapes use more than five parts, which are joined together, and which use at least the first aspect of the invention. This system works as the four-part shape, however, multiple additional loose parts are also used to connect the parts connected to the target and graft vessel. This form is well applicable for all anastomosis types, and will mainly occur with STS anastomoses.

1010386

Claims (29)

An anastomotic device for connecting a graft vessel to a target vessel at a connection opening therein, comprising: 5. an essentially tubular body with a bottom edge to be directed towards the target vessel; an externally mounted or attachable outer flange mounted on the tubular body and engageable around the connection opening against the outside of the target vessel wall; and 10 - an inner flange formed on the tubular body which protrudes in a free state relative to the tubular body and can abut in overlapping relationship with the outer flange around the connection opening against the inside of the target vessel wall, and which from that free state is reversibly bent against a resilience to a prestressed state in which its projection on the surface clamped by the bottom edge lies substantially on and / or within that bottom edge such that the inner flange can be inserted through the connection opening in the target vessel , and is fixed in that prestressed state in such a way that the fixation is releasable to cause the inner flange to bend back under the influence of the bias in the direction of the free state. Anastomotic device according to claim 1, wherein the outer flange is slidable in the longitudinal direction of the tubular body and / or in the direction of the inner flange and can be locked by means of locking means relative to the tubular body and / or the inner flange. Anastomotic device according to claim 2, for connection to a target vessel of the type in which the connection opening is formed in the wall and wherein the distance from the outer flange to the outwardly projecting inner flange is adjustable or adjustable. Anastomotic device according to claim 2 or 3, wherein the locking means comprise a sawtooth mechanism. Anastomotic device according to any of the preceding claims, wherein the inner flange is made of a super-elastic metal alloy or a thermally activated / activable shape memory alloy, such as a nickel-titanium alloy (e.g. Nitinol). a a r o Λ r ', I U i vv o u Anastomotic device according to any of the preceding claims, wherein the inner flange has a bend axis extending tangentially to the lower edge of the tubular body at the inner circumference of the outer flange. Anastomotic device according to one or more of the preceding claims, wherein the inner flange comprises a number of legs arranged mutually separated by cuts, recesses or pleats, distributed over the circumference of the tubular body, the cuts or recesses or pleats preferably continuing to or beyond the outer flange. Anastomotic device according to one or more of the preceding claims, wherein the surface of the inner flange or legs facing the inner wall of the target vessel in the free state is provided with a roughening or unevenness. Anastomotic device, preferably according to one or more of the preceding claims, wherein the anastomotic device, at least the lower edge of the tubular body thereof, has a substantially oval or elliptical shape / contour. 10. Anastomotic device, preferably according to one or more of the preceding claims, for connecting a graft vessel to a target vessel at a connection opening therein, such as in particular a connection opening present in the wall thereof, comprising an outer flange which is intended to be abutted with an outer flange abutment surface around the opening against the outside of the target vessel wall, characterized in that the outer flange abutment surface is cylindrically curved, preferably having a radius of curvature equal to or approximately equal to the outer circumferential radius of the target vessel at the connection opening. An anastomotic device according to claim 10, wherein the outer flange abutment surface is in the form of substantially a cylinder sector extending over at most 180 °, preferably over 150 ° to 180 °. 12. Anastomotic device according to claim 10 or 11, wherein the radius of curvature of the outer flange contact surface is in the range from 0.5 to 1.25 mm or in the range from 15 to 25 mm. An anastomotic device according to any of claims 8-9, further comprising an inner flange which is intended to be interrupted or not; .... _. Inner flange abutment surface to be brought into abutment around the opening against the inner side of the blood vessel wall, characterized in that the inner flange abutment surface is cylindrically curved with a radius of curvature equal to or approximately equal to the inner circumferential radius of the target vessel is at the connection opening; or equal or approximately equal to the radius of curvature of the outer flange contact surface. Anastomotic device according to claim 13, wherein the radius of curvature of the inner flange contact surface is in the range of 0.5 to 1.25 mm or in the range of 15 to 25 mm. Anastomotic device, preferably according to one or more of the preceding claims, further comprising coupling means, optionally integrally formed with the tubular body or the outer flange, for attaching the free end of the graft vessel to the tubular body or for attaching the anastomotic device to a further anastomotic device. Anastomotic device according to claim 15, wherein the coupling means comprise an accessory with at least a part that can be inserted into the tubular body, with a passage for the graft vessel. An anastomotic device according to claim 16, wherein the tubular body and / or the attachment is preferably provided with a stop which is arranged to prevent the attachment from protruding beyond the bottom edge of the tubular body. 18. Anastomotic device according to claim 17, wherein the stop is arranged such that in the inserted position the fitting extends with its lower end up to the lower edge. An anastomotic device according to any one of claims 15-18, wherein the coupling means comprises a series of suture passages distributed radially through the tubular body or accessory, circumferentially disposed over the circumference of the tubular body or separate accessory, the passages preferably have a diameter of 0.5 to 1.5 mm. Anastomotic device according to any one of claims 15-19, wherein the coupling means comprise a flexible and / or resilient ring, which is dimensioned such that the connecting end of the graft vessel can be passed through it and 1 0 1 0 o ö "o (f this can be retracted, and wherein an inner circumferential surface of the anastomotic device, preferably of the tubular body thereof, is provided with an inwardly opening circumferential groove in which the ring can be received together with a part of the recessed end of the graft vessel. , preferably in a form-fitting manner. The anastomotic device of claim 20, wherein the circumferential groove opens obliquely downward into the target vessel. Anastomotic device according to claim 20 or claim 21, wherein two or more rod-shaped members are mounted on the ring which are substantially perpendicular to the ring 10, extend in axial direction thereof, and are attached at their other ends to a flexible sleeve. An anastomotic device according to any one of claims 15-19, wherein the coupling means comprise an externally tapered sleeve, which is dimensioned such that the connecting end of the graft vessel can be passed through it and can be retracted over it, and a clamping ring which can be the narrow end intermediate the retracted portion of the graft vessel to slide over the sleeve until clamped. Anastomotic device, preferably according to one or more of the preceding claims, wherein the passage through the tubular body and / or the passage 20 through the fitting insertable therein and / or the coupling means are arranged such that the graft vessel is connected at an angle. uneven 90 °, preferably less than 70 °, such as, for example, 60 °, 45 ° or 30 °, with respect to the target vessel. 25. Anastomotic device according to one or more of the preceding claims, wherein the device is made of or covered with a material inert to the human or animal body. Anastomotic device according to any of the preceding claims, wherein the inner flange and / or legs and / or blood-contacting parts of the anastomotic device are manufactured and / or coated with anticoagulant materials. Anastomotic device for interconnecting two vessels at connection openings present therein, preferably according to one or more of the preceding claims, comprising a first anastomotic device for attachment to one vessel of the vessels to be joined and a second anastomizer r. . j; The device means for attachment to the other vessel of the vessels to be joined, wherein the anastomotic device means at the connection openings have an essentially round shape and are mutually connectable in a manner rotatable about a rotation axis perpendicular to the connection openings. An anastomotic device according to claim 27, wherein the one anastomotic device means on its side facing the other anastomotic device means has a round slit, preferably rear-cut, extending around the connecting opening, and wherein the other anastomotic device means on its the side facing the slot is provided with a continuous or discontinuous round rib extending around the connecting opening, which is, preferably form-fitting, accommodated or received in the slot. An anastomotic device according to claim 28, wherein the rib is a discontinuous rib, which is built up of rib segments arranged distributed around the connection opening. 1 01 Ü3ÜÖ